The stakes are high for FemTech – as Benjamin Franklin noted: ‘it takes many good deeds to build a good reputation and only one bad one to lose it.’...more
7/19/2024
/ Consumer Privacy Rights ,
Data Protection ,
Data Protection Impact Assessments (DPIAs) ,
EU ,
Mobile Health Apps ,
Patient Privacy Rights ,
Personal Data ,
Regulatory Requirements ,
Risk Management ,
Sensitive Personal Information ,
Technology Sector ,
UK
Security, scale or functionality – pick two. This computer science principle coined by the late Professor Anderson is particularly relevant to the FemTech industry. Anderson’s Rule states that for a system to provide high...more
5/17/2024
/ Business Strategies ,
Digital Health ,
EU ,
General Data Protection Regulation (GDPR) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Health Technology ,
Innovation ,
Life Sciences ,
Med Tech ,
Popular ,
UK
On November 17, 2023, the Centers for Medicare and Medicaid (CMS) published a final rule implementing additional disclosure requirements for U.S.-located, Medicare skilled nursing facilities and Medicaid nursing facilities...more
On October 30, 2023, the U.S. Department of Health and Human Services (HHS) released a proposed rule (Proposed Rule) to establish disincentives for healthcare providers that engage in information blocking under the 21st...more
In recent years, private equity firms and retail giants like CVS and Walmart have acquired many physician practices and physician practice management organizations across the country. As healthcare has become increasingly...more
11/3/2023
/ Acquisitions ,
Amended Regulation ,
Competition ,
Corporate Practice of Medicine ,
CVS ,
Health Care Providers ,
Industry Consolidation ,
New Regulations ,
Physicians ,
Private Equity ,
Regulatory Oversight ,
State Health Departments ,
Wal-Mart
This August, the Centers for Medicare and Medicaid Services (CMS) announced multiple changes (to take effective in performance year 2024) to one of its alternative payment models, the Accountable Care Organization Realizing...more
Representations and Warranties Insurance (RWI) has increasingly become a tool employed by both Buyers and Sellers to shift away from the traditional indemnification model of escrows or other mechanisms that could tie up...more
8/2/2023
/ Acquisitions ,
Commercial Insurance Policies ,
Corporate Practice of Medicine ,
Cybersecurity ,
Medical Malpractice ,
Mergers ,
Patient Privacy Rights ,
Policy Terms ,
Professional Liability ,
Representations and Warranties ,
Risk Assessment ,
Terms and Conditions ,
Underwriting
Five years ago Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”). Aimed at combating kickbacks in the addiction treatment industry, EKRA prohibits remunerations in return for patient referrals to...more
7/21/2023
/ Anti-Kickback Statute ,
Clinical Laboratories ,
Compliance ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
Fraud ,
Fraud and Abuse ,
Health Care Providers ,
Laboratories ,
Patient Referrals ,
Safe Harbors ,
Substance Abuse
This Tuesday, April 18, 2023, the U.S. Supreme Court heard argument in U.S. v. SuperValu. SuperValu is the second – and more consequential – False Claims Act (FCA) case of the term....more
Attorneys and compliance professionals in the health care industry are routinely required to help their clients interpret complex laws and regulations, often without sufficient authoritative guidance from regulators. Because...more